ipilimumab plus SoC (n=250) vs. placebo plus SoC (n=252)
randomized controlled trial
ipilimumab plus dacarbazine
ipilimumab plus dacarbazine (10 mg per kilogram plus 850 mg per square meter of body-surface area) given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeksthrough week 22.
dacarbazine plus placebo
dacarbazine (850 mg per square meter) plus placebo given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeks through week 22.
No cross over, they were eligible to enter a maintenance phase in which they received placebo or ipilimumab every 12 weeks.
mML - L2 - all population
patients were ineligible if they had evidence of brain metastasis (as confirmed on imaging), primary ocular or mucosal melanoma, or autoimmune disease
double-blind
multinational
P3/ two sided test procedure without interim analysis. A hierarchical testing procedure was implemented in the order of the following end points: overall survival, progression- free survival, rate of disease control, and rate of best overall response
Ipilimumab (at a dose of 10 mg per kilogram) in combination with dacarbazine, ascompared with dacarbazine plus placebo, improved overall survival in patients withpreviously untreated metastatic melanoma.